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FDA panel backs prescribing opioid antidote alongside painkillers

FDA panel backs prescribing opioid antidote alongside painkillers
FDA panel backs prescribing opioid antidote alongside painkillers

Advisers to the Food and Drug Administration recommended Tuesday that labels on prescription opioids urge doctors to simultaneously prescribe the overdose antidote naloxone for at least some of their patients.

Several members of two advisory committees, which met jointly, described their 12-to-11 vote as a message to the government that the fast-acting antidote must be made more widely available, at lower cost and with fewer barriers to obtaining it.

The FDA is not required to follow the recommendations, but the expert panels are influential in crafting policy.

Naloxone, which can be injected or sprayed into the noses of overdose victims, has been available for decades and saved countless lives during the opioid epidemic. But it still is provided mostly by first responders and harm-
reduction groups that distribute it to illicit drug users, as well as by cities and states that have issued “standing orders” for prescriptions for anyone who wants to purchase it at a drugstore.


In April, U.S. Surgeon General Jerome M. Adams issued an unusual advisory urging American opioid users, their families and friends to keep naloxone nearby.

Martin Garcia-Bunuel, a committee member and official with the Veterans Affairs Maryland Health Care System in Baltimore, said he voted for the recommendation in hopes of prompting discussion between doctors and patients about keeping naloxone in the home alongside opioids.

“If done properly, it will help create a conversation, standardize a conversation that protects patients who aren’t getting this conversation,” he said.

But other committee members said it makes little sense to recommend a naloxone prescription for everyone who uses the painkillers, since most overdose deaths occur among illicit users of narcotics. Some suggested the recommendation be targeted at high-risk groups, such as people with respiratory problems or histories of abusing prescription narcotics. Others worried the guidance could lead to shortages of the antidote.

U.S. health-care providers wrote more than 191 million prescriptions for opioids in 2017, according to the Centers for Disease Control and Prevention.

“Co-prescribing is the least-
effective method we talked about in terms of actually providing product to the patient,” said Raeford E. Brown Jr., a professor of anesthesiology at the University of Kentucky’s College of Medicine, who chaired the two-day meeting.

More than 70,000 people died of drug overdoses in 2017, with 47,600 succumbing to opioids, according to the CDC. Both totals are records. The number of deaths caused by prescription narcotics leveled off from the previous year, but the number of deaths from overdoses of the opioid fentanyl continued to skyrocket.

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FDA panel backs prescribing opioid antidote alongside painkillers


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